WaveOne Gold Rotary File WGPRIME21Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Reciprocating File Primary 21mm · Class 1
All models of WaveOne Gold Rotary File (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI D716WGPRIME211), received between Sep 27, 2023 and Dec 29, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Break” (11 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break11
Patient problems
- Device Embedded In Tissue or Plaque11
- Insufficient Information3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE TOOTH, THE PATIENT WILL BE MONITORED AND FOLLOWED UP WITH AFTER ROOT CANAL TREATMENT. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23906779 ↗MalfunctionJul 28, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART HAS NOT YET BEEN RETRIEVED AS OF THIS MDR. RETRIEVAL OF THE BROKEN PART IS PLANNED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22636899 ↗MalfunctionJun 12, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22193061 ↗MalfunctionApr 28, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21919197 ↗MalfunctionMar 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21643609 ↗MalfunctionMar 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21643507 ↗MalfunctionMay 23, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE PRIMARY 21MM BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL AND FURTHER TREATMENT IS PLANNED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19382145 ↗MalfunctionNov 21, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 18181543 ↗MalfunctionNov 21, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 18181528 ↗MalfunctionNov 21, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 18181107 ↗MalfunctionSep 27, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 21MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17824112 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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